Clinical Trial: Evaluate the Efficacy and Safety of Pletaal (Cilostazol) in Subjects With Vasospastic Angina

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of PletaalÒ(Cilostazol) in Subjects With

Brief Summary: The objective of this study is to investigate the efficacy and safety of Pletaal (Cilostazol) in comparison with placebo for 4 weeks in vasospastic angina patients who have an insufficient response to Amlodipine (Calcium channel blocker).

Detailed Summary:

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic exploratory Study.

The subject who has at least an episode of chest pain weekly despite Amlodipine 5mg once a day (qd) taking during 2 weeks will have treatment of Pletaal (Cilostazol) or Placebo for 4 weeks. Pletaal (Cilostazol) is taken 100mg oral tablets two times a day (bid) during 2 weeks after dosing of Pletaal (Cilostazol) 50mg oral tablets bid during 2 weeks. Placebo of Pletaal (Cilostazol) is used as the control medication.


Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Current Primary Outcome: Percent change of the chest pain frequency [ Time Frame: A week before IP dosing and the final a week after IP dosing (average 6weeks) ]

Collect the chest pain frequency data related with vasospastic angina episodes by subject diaries.

Descriptive statistics (N, mean, standard deviation, minimum, median and maximum) will be presented by treatment group. ANCOVA will be performed between the treatment groups using the baseline (a week before IP dosing) as covariate.



Original Primary Outcome: Same as current

Current Secondary Outcome: The chest pain frequency, the pain intensity, nitroglycerin consumption of the final a week after IP dosing from a week before IP dosing [ Time Frame: A week before IP dosing and the final a week after IP dosing (average 6weeks) ]

Descriptive statistics (N, mean, standard deviation, minimum, median and maximum) will be presented by treatment group. ANCOVA will be performed between the treatment groups using the baseline (a week before IP dosing) as covariate. The subject who has no chest pain will be regarded as the total pain intensity and the average pain intensity are '0'. The subject who has taken no nitroglycerin will be regarded as taking '0' tablet.


Original Secondary Outcome: Same as current

Information By: Korea Otsuka Pharmaceutical Co., Ltd.

Dates:
Date Received: September 27, 2011
Date Started: October 2011
Date Completion:
Last Updated: July 13, 2012
Last Verified: July 2012